(60 days)
The In2Bones Ankle Fusion plating system is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.
The addition of a compression screw through the tibiotalar joint (example IBS™ 6.5mm screw) is required.
The Ankle Fusion Plating System is composed of an anatomically contoured plate, with a distal part adapted to the talar neck, and a proximal part adapted to the distal tibial epiphysis and diaphysis. Rigid fixation is achieved by screws.
The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V. A dedicated instrument set is available for the bone preparation, screw sizing and insertion of the Ankle Arthrodesis Plating System. A specific targeting device is available for the insertion of the additional I.B.S® 6.5mm screw.
Sizes: The Ankle Fusion Plate is available in one size, with left and right versions. Fixation screws are available in 3.5 or 4.5mm diameter, with length ranging from 10 to 100mm.
Material: The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V, as per ISO 5832-1 and ASTM F136.
Single use: The Ankle Fusion Plating System is designed for single use only.
Sterilization: The Ankle Fusion Plating System is supplied sterile, using gamma irradiation.
Place of use: The Ankle Fusion Plating System is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
I am sorry, but the provided text does not contain the detailed information needed to answer your request regarding acceptance criteria and a study proving device performance on an AI/ML device.
The document is a 510(k) premarket notification letter from the FDA for an "Ankle Fusion Plating System," which is a metallic bone fixation appliance, not an AI/ML device.
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size and data provenance for an AI/ML test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for an AI/ML test set.
- Multi-reader multi-case comparative effectiveness study results for AI assistance.
- Standalone performance of an algorithm.
- Type of ground truth for an AI/ML device.
- Sample size for an AI/ML training set.
- How ground truth for an AI/ML training set was established.
The "Summary Performance Data" section in the document broadly states: "Performance testing of the Ankle Fusion Plating System was assessed through mechanical bench testing performed by an independent test laboratory, animal and clinical testing being considered not applicable. Testing performed included static and dynamic compression tests on Ankle Fusion Plating System. The results indicate that the Ankle Fusion Plating System met the acceptance criteria." This refers to mechanical testing of a physical implant, not an AI/ML system.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.